BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECSYS TROPONIN T HS

    MDR report key: 21926443 · Received April 29, 2025

    Report

    Report Number
    1823260-2025-01335
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 6, 2025
    Report Date
    May 21, 2025
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K201441
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CALIBRATION AND QC WERE ACCEPTABLE. DURING A REVIEW OF THE ALARM TRACE DATA, NUMEROUS ALARMS RELATED TO SAMPLE QUALITY (SAMPLE FOAM DETECTION) OCCURRED. SAMPLE FOAM DETECTION (SFD) IMAGES WERE REVIEWED FOR THE AFFECTED SAMPLE, AND NO OBVIOUS ISSUES WERE OBSERVED. THE INSTRUMENT SURFACE WAS CLEAN AND FREE OF DUST/DEBRIS. FIFTY-NINE SFD IMAGES WERE REVIEWED, AND NUMEROUS SAMPLES SHOWED BUBBLES OR WHITE PARTICLES ON THE SAMPLE SURFACE. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM.

    Additional Manufacturer Narrative · 0

    THE E801 ANALYZER SERIAL NUMBER WAS (B)(6).

    Description of Event or Problem · 0

    THE INITIAL REPORTER COMPLAINED OF DISCREPANT RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS TROPONIN T HS (TROPONIN T HS) ON A COBAS E 801 ANALYTICAL UNIT. THE INITIAL RESULT WAS 179 PG/ML. THE SAMPLE WAS REPEATED TWICE, WITH RESULTS OF 206 PG/ML AND 222 PG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428870 ELECSYS TROPONIN T HS IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ROCHE DIAGNOSTICS 81184801

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown